Table 3 Data extraction table from update search: Clinical effectiveness and safety of implantable bulking agents (Sphinkeeper™ [THD s.p.A., Italy]) for faecal incontinence
Product | Sphinkeeper™ | |
|---|---|---|
References | Dawoud [36] | Colbran [37] |
Country | Austria | Australia |
Sponsor | None (no CoI) | None (no CoI) |
Comparator | None | None |
Study design | Prospective, before-after, single-arm, single-centre | Prospective, before-after, single-arm, single-centre |
Conducted in | 2018–2020 | 02/2018–09/2019 |
Indication | Refractory FI | FI not specified |
Intervention | Median: 9 prostheses | 10 prostheses |
Number of pts at baseline | 11 (9 females) | 13 (11 females) |
Number of pts analysed | 11 (9 females) | 12 (females: NR) |
Loss to FU, n (%) | 0 (0) | 1 (7.7) |
Age of patients, yrs median (range) [36] Mean age ± SD [37] | 75 (46–89) | 56.7 ± 12.7 |
Inclusion criteria | Failure to respond to conservative treatment | > 18 yrs FI symptoms > 12 months Ongoing symptoms despite conservative measures FI episodes > 1x/week |
Exclusion criteria | Malignant disease Rectal bleeding of unknown origin Inflammatory bowel disease | Malignancy Inflammatory bowel disease Untreated rectal prolapse Acute perianal sepsis Obstructed defaecation syndrome or chronic constipation Neurological disease Previous rectal resection and sphincter defects > 120º |
Clinical outcome measures | Clinical effectiveness: FI severity (Vaizey [= St Mark’s incontinence score]) Safety: migration of prostheses (3D endo-anal ultrasound) | Clinical effectiveness: FI severity (CCFI, Vaizey), QoL (FIQL) Safety: positioning of the prostheses (3D endo-anal ultrasound) |
FU, months | Median: 8 (range 3–18) | 3, 12 |
Outcomes | ||
Clinical effectiveness | ||
Faecal incontinence severity | ||
Preoperative | 22 points | 10.5 ± 9.5 |
Postoperative 3 months | NR | 9.0 ± 10.8 |
Postoperative 8 months | 13 points; p = 0.008 | NR |
Postoperative 12 months | NR | 9.0 ± 10.3; p = 0.264 |
CCFIS (mean ± SD [37]) | ||
Preoperative | NR | 10.8 ± 4.9 |
Postoperative 3 months | NR | 9.3 ± 5.8 |
Postoperative 12 months | NR | 8.3 ± 6.2; p = 0.175 |
FIQL: lifestyle (mean ± SD [37]) | ||
Preoperative | NR | 2.8 ± 2.8 |
Postoperative 3 months | NR | 3 ± 1.5 |
Postoperative 12 months | NR | 3.4 ± 1.7; p = 0.527 |
FIQL: coping/behaviour (mean ± SD [37]) | ||
Preoperative | NR | 1.9 ± 0.9 |
Postoperative 3 months | NR | 2.4 ± 1.0 |
Postoperative 12 months | NR | 2.6 ± 1.0; p = 0.047 |
FIQL: depression/self-perception (mean ± SD [37]) | ||
Preoperative | NR | 2.75 ± 1 |
Postoperative 3 months | NR | 3.3 ± 1.6 |
Postoperative 12 months | NR | 3.1 ± 1.5; p = 0.132 |
FIQL: embarrassment (mean ± SD [37]) | ||
Preoperative | NR | 2.2 ± 1.0 |
Postoperative 3 months | NR | 2.3 ± 0.8 |
Postoperative 12 months | NR | 2.6 ± 1.0; p = 0.156 |
Outcomes | ||
Safety (n [%]) | ||
Procedure-related adverse events | ||
Intraoperative complications | 0 (0) | 1 (7.7) (rectal perforation) |
Postoperative complications/morbidity | NR | NR |
Infection/sepsis/ inflammation | NR | NR |
Anal discomfort/pain, analgesia > 48 h | 1 (9) | NR |
Adverse effect/reaction/general complication | NR | NR |
Device-related adverse events | ||
Dislodgement of prostheses | 10 (91) | NR |
Prosthesis removed/extruded | 1 (9) | 3 (23.1) |